Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Less Than 11 Tender Points at Month 6
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged greater than or equal (>=) 18 years
- •Fibromyalgia diagnosed at least one year before
- •History of generalized pain and at least 16 positive tender points (1990 American College of Rheumatology [ACR] criteria)
- •Body Mass Index (BMI) less than or equal to(=<) 32
- •Normal GH stimulation test (insulin)
- •Stable (>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram per day [mg/day]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus tramadol (25-400 mg/day)
- •Active rehabilitation program during the previous year (at least 30 minutes/day)
- •Fibromyalgia Impact Questionnaire (FIQ) score >=75
- •IGF-1 serum level =< 150 nanogram/milliliter (ng/mL) otherwise =< 2 SD of the local lab normality)
- •Normal response to IGF-1 generation test
- •Chronic Fatigue Symptoms (Multidimensional Assessment of Fatigue [MAF])
- •Effective anti-conception
- •Willingness to comply with the protocol
- •Written Informed consent
排除标准
- •Major psychiatric condition
- •Rheumatic disease, including systemic lupus erythematosus (SLE)
- •Previous or current malignancies, active or inactive
- •Clinical history intracranial space occupying lesion
- •Reactive or secondary (rheumatoid arthritis [RA], osteoarthritis) fibromyalgia syndrome (FMS)
- •Antinuclear antibody (ANA) greater than or equal 1:80
- •Abnormal Creatine phosphokinase (CPK) or aldolase serum levels
- •Not controlled thyroid disease in the last 3 months (free Thyroxine [T4] and Thyrotrophin-stimulating hormone [TSH] serum levels)
- •Diabetes mellitus
- •Adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour cortisoluria)
- •Pregnancy or breast feeding
- •Known to be hypersensitive to somatotropin or any of the excipients
研究组 & 干预措施
Saizen®
干预措施: Saizen® (Drug)
Placebo + Saizen®
干预措施: Placebo and Saizen® (Drug)
结局指标
主要结局
Percentage of Participants With Less Than 11 Tender Points at Month 6
时间窗: Month 6
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
Percentage of Participants With Less Than 11 Tender Points at Month 12
时间窗: Month 12
The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.
次要结局
- Fibromyalgia Impact Questionnaire (FIQ) Total Score(Baseline, Month 1, 3, 6, 7, 9 and 12)
- Visual Analog Scale (VAS) Total Score(Baseline, Month 1, 3, 6, 7, 9 and 12)
- EuroQol 5-Dimensions (EQ-5D) Total Score(Baseline, Month 1, 3, 6, 7, 9 and 12)
- Multidimensional Assessment of Fatigue (MAF) Total Score(Baseline, Month 6 and 12)
- Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale(Baseline, Month 6 and 12)